Asthmatic pregnant women, who are taking medications for their condition, may have a slightly higher risk of having babies with rare birth defects.  That’s according to new research published in Journal Pediatrics.  However, the researchers hasten to add that the increased risk is only slight, and that there are no firm conclusions about the cause of the defects.

Overall, according to the researchers, pregnant women who took the asthma medication in the month before they conceived and right through the 3rd month of pregnancy seemed to be at a slightly higher risk of delivering babies with birth defects.  The defects that were noticed were relatively rare, and included incomplete development of the esophagus, intestines sticking out of the belly button, and missing opening of the anus.

These are extremely rare defects, but the use of antiasthma medications including steroids and bronchodilators seemed to increase their risk slightly in some women.

Overall, the researchers say that they do not know whether the slightly increased risk of asthma is due to the medications themselves or the intensity of the asthma.  He researchers do not recommend that pregnant women stop taking their medications because of the results of the study.  They say that there is no firm conclusion to prove that the medication is linked to the increased risk of birth defects.  However, they don’t completely discount the possibility that the medication could cause a slight increase in birth defect risks.  As of now, researchers say that they are not in a position to completely confirm the safety of these medications.

California product liability attorneys would recommend that pregnant women continue to take their asthma medications, and keep the doctor informed about their condition.

The Darvocet lawsuits continue to pile up.  The family of a Louisiana woman who suffered a fatal heart attack after prolonged use of the painkiller Darvocet, has filed a wrongful death lawsuit against a number of pharmaceutical companies, including Eli Lilly and Xanodyne Pharmaceuticals.

According to this particular lawsuit, the woman’s death was caused by a heart attack brought on by Darvocet use.  The lawsuit has been filed in a New Orleans court.

The increased risk of cardiac injuries or heart attack from prolonged use of Darvocet and Davon has been at the core of hundreds of lawsuits filed by persons injured by the use of these painkillers.  Darvocet is a painkiller that contains a combination of acetaminophen and propoxyphene.  Darvon, on the other hand contains only propoxyphene.

In 2010, the Food and Drug Administration announced a recall for both Darvon and Darvocet, after studies concluded that both of these painkillers increased the risk of heart attacks. Specifically, the study concluded that the prolonged use of these medications caused a change in electrical cardiac activity, increasing the risk of the person suffering from cardiac arrhythmias.  The person’s risk of other conditions, including myocardial infarction, also was found to increase with Darvocet use.

Both painkillers have since been pulled from the market, but not before possibly thousands or hundreds of thousands of Americans were exposed to their effect.

Cardiac injuries are not the only kind of side effects that California Darvocet recall lawyers associate with Darvocet use.  These painkillers have also been linked to a number other minor side effects, including dizziness, fatigue, nausea, vomiting and constipation.  More serious side effects include anxiety, loss of appetite, severe weight loss, and fatigue.  Darvocet has also been linked to the risks of addiction.

Many prescription errors that result in patients having to be rushed to hospital emergency rooms, are the result of prescription errors made while administering the dosage.  California pharmaceutical injury lawyers often find that many of these errors are caused because the information provided in the literature that is given to patients with the prescription, can be confusing and hard to decipher.  The Food and Drug Administration is now considering an initiative that would condense prescription drug information, and make it easy for consumers to understand.

The agency is working with the Brookings Institution, and is evaluating a single-page patient information sheet that can be given to patients with the prescription, in place of the complex literature that a patient currently receives.  The process of developing a patient information sheet like this has already begun.

In February, Brookings Institution’s Engelberg Center for Health Reform conducted a workshop to discuss prototypes of the one-page format.  This is uncharted territory as far as the size of the sheet is concerned.  The FDA believes that a single page information sheet would be just right.  Most of the essential information will be included in the sheet.  For further information, consumers would be encouraged to look for information on relevant websites.

If there are new patient information sheets developed as a result of this initiative, it could mean that hundreds of thousands of patients every year would have standardized, simple, easy-to-read and understand instructions. These would provide not just information about the dosage of the medication, but also the dosing schedule, as well as the purpose for which the medication should be taken.  This could prevent many prescription drug errors every year.

GlaxoSmithKline’s Avandia-related problems continue. This week, the company announced that it had revised its labeling for Avandia packaging in line with the Food and Drug Administration’s directives. The company has also settled more Avandia injury and wrongful death lawsuits for $250 million.

The labeling on the Avandia packaging has now been modified to restrict the use of rosiglitazone, the key ingredient in Avandia, to patients already taking the drug or those who have not found any benefit through any other anti-diabetes drugs. According to the label, rosiglitazone may be prescribed only to patients who are unable to achieve adequate glycemic control with other diabetes medications. The label specifically restricts the use of Avandia to those who have decided not to take pioglitazone for medical reasons.

Earlier this year, the Food and Drug Administration disappointed California pharmaceutical liability attorneys by stopping short of a complete ban on the medication. The new and improved labeling has been part of the FDA’s conditions for keeping Avandia on the market. The label would restrict its use to far fewer patients. The European Union was not in the mood to be as lenient with GlaxoSmithKline. Earlier this year, the EU medicine agency imposed a complete ban on the sale of Avandia.

The anti-type II diabetes drug has been linked to cardiac vascular problems, including heart attacks among users. This has been the basis of thousands of lawsuits filed against GlaxoSmithKline. Avandia has also been linked to other health issues, including eye disorders and a higher risk of osteoporosis in women.

Also last week, GlaxoSmithKline announced its latest settlement with personal injury and wrongful death plaintiffs. The company is to pay out $250 million in settlement of at least 5,500 lawsuits.

California pharmaceutical liability attorneys can add one more product to a long list of nutritional, herbal and dietary supplements that have been recalled over the past year for health hazards. In this latest case, the Food and Drug Administration has warned that PRock Marketing LLC will soon announce a recall of all Fruta Planta weight-loss products. That announcement came after testing by the agency found signs of sibutramine in the products. Sibutramine has already been withdrawn from the market because of risks to consumer health.

The company is recalling Fruta Planta and the Reduce Weight Fruta Planta. According to the Food and Drug Administration, there have been several reports of adverse events that have been associated with the use of these weight-loss products. In some cases, persons who used these products suffered adverse cardiac events. At least one death has been traced to the use of these products. The agency is advising consumers to stop using the products immediately, and discard any product that they already have. Consumers can also return the product to the company.

Fruta Planta weight-loss products were promoted as all-natural organic Chinese weight-loss products that help eliminate body fat. According to the company, consumers could lose as many as 15 pounds in the first month of taking the products, without the help of any diet or exercise.

The FDA action on this supplement comes just a few weeks after the agency wrote a general letter to the nutritional and herbal supplement industry, expressing its concern about improper labeling of some of these products. Much of the problem is that the Food and Drug Administration approval is not required for herbal/dietary/nutritional supplements before they are released into the market. According to the FDA, some of these products include ingredients that do not qualify as dietary ingredients.

If California pharmaceutical liability attorneys thought that the recent uproar over quality control failures at Johnson & Johnson would force the company to revise its standards, they would be mistaken.  The company has announced yet another recall of over-the-counter products, including its blockbuster medication, Tylenol.

This recall also seems to be linked to a malodorous product.  According to McNeil Consumer Healthcare, the Johnson & Johnson unit that was also linked to the previous recall of over-the-counter products, the company is recalling batches of Tylenol eight-hour caplets.  These caplets are available in bottles of 50.  Approximately 120,000 bottles are included in the recall.  This recall is also linked to a musty smell emanating from the packaging.

The musty odor comes from contamination of 2,4,6-tribromoanisole, a chemical preservative in wooden pallets that are used to ship packing boxes.   There are no studies to indicate that there are serious health effects from tribromoanisole.  However, other Johnson & Johnson recalls earlier this year were linked to complaints from consumers who suffered from nausea, vomiting, abdominal pain and diarrhea after taking the medication.

This recall couldn’t come at a worse time for Johnson & Johnson.  The company is already facing plenty of heat over a phantom recall that it conducted to shield the recall from federal regulators.  In January this year, the company recalled 50 million bottles of a number of over-the-counter products, including children’s and adult Tylenol, Motrin, Rolaids and St. Joseph’s aspirin.  The products were manufactured at the company’s Fort Washington, Pennsylvania plant, which has since been closed indefinitely.  The closure of the plant came after investigations by the Food and Drug Administration.  According to the agency, inspectors found dust, grime and contaminated ingredients at the facility.

After Glaxo’s Avandia, it’s now the turn of its closest rival, Actos, to be in the spotlight.  The Food and Drug Administration has announced that it is beginning a safety review of the anti-diabetes drug manufactured by Takeda Pharmaceuticals Co., Ltd.  The agency is looking at a heightened risk of developing bladder cancer among patients who take Actos.

According to the FDA, the data seems to indicate a heightened risk of developing bladder cancer in patients who have had long-term exposure to Actos.  These risks have also been seen in those patients who have had exposure to even a small dose of the drug.  The findings came from five-year data included in a ten-year trial by the drug maker.  According to the study, patients who used Actos were 20% more likely to be diagnosed with bladder cancer, but so far, those findings have been deemed statistically insignificant.

At this point, the Food and Drug Administration is not confirming that there is an increased risk of bladder cancer among long-term users of Actos, who have used the drug for two years or more.  The agency is also not advising patients to stop using Actos.  If you’re on Actos, you should continue using the drug. If you have any health concerns, talk to your physician about them.

This focus on Actos comes as California pharmaceutical liability lawyers increase pressure on its closest competitor, Glaxo Smith Kline’s Avandia.  That anti-type II diabetes drug has been linked to a higher risk of heart disease.  People who have taken Avandia have been found to have a higher risk of suffering a heart attack or developing cardiac problems, compared to people who take Actos.  These concerns have led to calls for removing Avandia from the market altogether, a move that Glaxo Smith Kline has strongly resisted.

Nobody likes to admit it, but at some point, everyone has been suckered by a product that they’ve seen on television that promises to do this or that. Once we get it home, however, we discover that this miracle product is actually a total dud. We toss it in the trash and chalk it up to another example of “buyer beware.” When it comes to prescription drugs, though, false promises can be extremely hazardous. Two pharmaceutical giants, Johnson & Johnson and AstraZeneca, settled two separate lawsuits last month. Both lawsuits involve false claims, illegal marketing and unapproved uses of two highly-profitable and extremely popular medications.

Johnson & Johnson paid out $81 million to settle a case that claimed it marketed the epilepsy drug Topamax for unapproved psychiatric uses. Topamax was thrust into the legal system after a Virginia psychiatrist filed a whistle blower lawsuit that assisted the Justice Department in making its case. His lawsuit claimed that the company promoted Topamax for unapproved treatments for alcohol dependence to weight loss and that Johnson & Johnson gave doctors financial kickbacks. J&J pleaded guilty to a single criminal charge. Six million of the settlement will pay a criminal fine, while the rest of the money will resolve civil claims that the company’s marketing of the drug led government health programs to pay for Topamax for unapproved uses.

AstraZeneca’s false marketing came with a steeper price tag: $520 million. The drug giant had marketed its anti-psychotic medication Seroquel for uses that the Food and Drug Administration had not approved. The suit alleged that AstraZeneca had encouraged doctors to prescribe Seroquel for a myriad of unapproved uses, from post-traumatic stress disorder to anger management. Like the J&J suit, the government claimed the company sweetened the deal for doctors by handing over money to prescribe the drug. AztraZeneca, however, has denied the allegations and agreed to pay the $520 million settlement.

Both Seroquel and Topamax also have faced class action suits from patients who claim the drugs didn’t deliver what they promised.

Neurontin, an antiseizure drug manufactured by New York-based pharmaceutical giant Pfizer, is yet another highly prescribed medication with deadly side effects. Approved in 1994 by the Food and Drug Administration to help sufferers of epilepsy with pain and partial seizure prevention, Neurontin has been found to increase suicidal thoughts and actions among patients who use the medication. In fact, the FDA found a startling 80 percent rise in suicidal thoughts and behaviors in data from nearly two hundred studies conducted by the agency.  These studies show Neurontin to be a harmful drug to a certain percentage of the population.

Last July, the first lawsuit against Pfizer went to trial. There are roughly 1200 other cases pending involving Neurontin. The most recent was brought to trial last week in a federal court in Boston, Mass., but both parties reached an agreement before the trial had ended.

Pfizer Inc. also announced that a settlement in a wrongful-death lawsuit was reached for an undisclosed amount on Monday. Linda Shearer, the plaintiff in the lawsuit, claimed her husband Hartley Shearer was prescribed Neurontin to control the effects of his paralysis and that his use of the drug caused him to commit suicide in 2002. The lawsuit also alleged that Pfizer promoted the use of Neurontin even though it was not approved by U.S. regulators and that Pfizer also knew of the suicide risks linked to the product but failed to warn consumers. While the exact details of the settlement are unknown, sources close to the case estimate the final number at no less than $400,000.

This settlement is another setback for Neurontin, a product with a history of legal woes and high-priced lawsuits. Last month, a federal jury found Pfizer guilty of violating an antiracketeering law by marketing Neurontin for off-label uses and awarded damages of $47 million, which is to be automatically tripled under the law. Pfizer said that it plans on filing an appeal and is currently pursuing a postmotion trial. The company also shelled out $430 million to settle a governmental investigation after pleading guilty to a criminal charge linked to the promotion of Neurontin.

Sufferes of diabetes thought they found a golden ticket in Avandia.  Backed with big bucks’ promotion and relentless advertising, Avandia appeared to be a friend to people with diabetes.  Sold as a diabetes management drug, Avandia was pushed on websites like diabetes.com and diabetesmanagment.com, which are sites owned by their maker, GlaxoSmithKline.  The sales skyrocketed and doctors across the country prescribed Avandia to millions.  Yet Advandia wasn’t all it appeared to be.  Two years of investigations and questions about the drug quietly simmered in the background.  GlaxoSmithKline has seen its stock drop this week and the Food and Drug Administration has called for an advisory committee to meet in July to discuss the safety of Avandia.  So what happened to the diabetes wonder drug?

The short answer is that GSK and the FDA have conflicting reports to just how dangerous Advandia can be.  The FDA is under fire for allowing clinical trials of the drug after scientists concluded that Avandia had caused over 80,000 heart attacks from 1999 to 2007, while GSK insists that the proper clinical trials have proven that Avandia is safe.  A Senate committee is currently probing the British pharmaceutical company as well.  Until the FDA’s committee findings however, the agency has informed patients currently using the drug to continue to do so unless their doctors advise them to stop.

Consumer advocates and legal experts however are advising that questions be asked and that the responsible parties be held accountable for a drug that could potentially cause heart attacks. Lawsuits involving wrongful death and injury regarding Avandia have been popping up in courthouse across the country for the past few years.  While the committees continue to meet and the drug companies continue to battle with the FDA, lives of patients hang in the balance.  In short, anything promising to be a wonder drug should be approached cautiously.

Related Information:  California Pharmaceutical Liability Attorney